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Miltenyi Biotec B.V. & Co. KG. (9/10/24). "Press Release: Miltenyi Biotec Manufactures Lentiviral Vector for Adaptimmune’s FDA-approved TCR T-cell therapy Tecelra (afamitresgeme autoleucel)". Bergisch Gladbach.

Region Region United States (USA)
Organisations Organisation Miltenyi Biotec, Gaithersburg
  Group Miltenyi Biotec (Group)
  Organisation 2 Adaptimmune Therapeutics plc (Nasdaq: ADAP)
  Group Adaptimmune (Group)
Products Product lentiviral vector
  Product 2 Tecelra®
Persons Person Lunger, John (Adaptimmune 202409 Chief Patient Supply Manager)
  Person 2 Kurz, Thekla (Milteny Biotec 202409 Global Head of Miltenyi Bioindustry division)
     


Miltenyi Biotec will supply lentiviral vector for TECELRA® (afamitresgene autoleucel), the first-ever TCR T-cell therapy for solid tumors approved by FDA on August 1, 2024.

The commercial manufacturing of the lentiviral vector used in production of TECELRA is performed by Miltenyi Bioindustry, the global division of Miltenyi Biotec dedicated to contract development and manufacturing organization (CDMO) services for the manufacturing of viral vectors and gene-engineered cell therapy products. Miltenyi Biotec and Adaptimmune have been working closely together since 2017 throughout clinical development, BLA submission, and preparations for commercial launch of this landmark therapy.

Successful FDA Pre-License Inspection

The lentiviral vector for TECELRA is manufactured at Miltenyi Biotec’s state-of-the-art, large-scale GMP facility in Gaithersburg, MD, USA. In May 2024, the site successfully hosted a US Food & Drug Administration (FDA) pre-license inspection, receiving approval for commercial-scale manufacturing of Adaptimmune’s lentiviral vector needs for TECELRA.

John Lunger, Chief Patient Supply Officer at Adaptimmune, said: “Miltenyi Biotec has been instrumental in supporting our journey to develop, evaluate in the clinical setting, and now commercially launch TECELRA. We are excited to continue our strong collaboration with Miltenyi Biotec now as we enter into the commercial phase of this groundbreaking new cell therapy to treat eligible patients with synovial sarcoma.”

Dr. Thekla Kurz, Global Head of Miltenyi Bioindustry division at Miltenyi Biotec, said: "With decades of pioneering expertise in the cell and gene therapy (CGT) arena from research to clinical to commercialization, Miltenyi Biotec is a recognized leader in this field. We are thrilled to be a commercial partner of Adaptimmune, united in the vision to bring ground-breaking cell therapies to patients in need.”

Miltenyi Biotec offers lentiviral vector services based on its proprietary large-scale, serum-free suspension manufacturing platform, an effort that began 10 years ago with the acquisition of Lentigen Technology Corp. in 2014, and now culminating in this landmark FDA approval. To date, more than 400 GMP batches of lentiviral vector have been produced and released worldwide, and the technology platform has enabled clinical trials of more than 100 customers around the world. Miltenyi Biotec’s comprehensive cell and gene therapy services offered within the Miltenyi Bioindusty division includes manufacturing cell therapy products utilizing our established workflow solutions, from cell processing to in-process control/quality control (IPC/QC).


About Miltenyi Biotec

Miltenyi Biotec is a global leader of innovative products and services that advance biomedical research and cellular therapy. The company's solutions support all stages of cell and gene therapy product development from process and analytical development to commercial-scale manufacturing. Its platform technologies have set industry standards in automated, integrated manufacturing and analysis of complex cellular products such as CAR T-cells, TCR T-cells, gene-modified NK and stem cells. Miltenyi Biotec’s comprehensive product portfolio is complemented by CDMO services for lentiviral vectors and cell manufacturing, in the Miltenyi Bioindustry division. The company has more than 4,900 employees in 24 countries and its products have been used in more than 150,000 cell therapy procedures.

Miltenyi Bioindustry, as a division of Miltenyi Biotec, uses its end-to-end expertise towards developing and manufacturing lentiviral vectors and cell and gene therapy products based on the CliniMACS Prodigy® fully automated cell manufacturing platform – from pre-clinical to commercial scale. Miltenyi Biotec is headquartered in Bergisch Gladbach, Germany, and maintains GMP facilities for cell manufacturing and lentiviral vector production in various sites across the globe. For further information please visit www.miltenyibiotec.com www.miltenyibioindustry.com and follow us on LinkedIn and X.


Contact

Miltenyi Biotec B.V. & Co. KG
Corporate Communications
Svea Lübcke
Mobile +49 151 17159 456
E-Mail [email protected]

   
Record changed: 2024-11-14

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